NAPLES, FL / ACCESS Newswire / November 19, 2025 / Patients battling aggressive blood cancers face limited treatment options and uncertain outcomes. Scientists have increasingly turned to the body's own defenses, developing therapies that empower natural killer (NK) cells to seek and destroy malignant cells. ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ Quarterly report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the quarterly period ended September 30, 2025. ☐ Transition report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the transition period from __________ to ____________. Commission File Number 001-40023 GT BIOPHARMA, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of ...

Financial Results - GT Biopharma, Inc. announced its financial results for the fiscal quarter ended September 30, 2025[4]. - The press release detailing the financial results was issued on November 14, 2025[4]. - The financial results include key metrics that will be detailed in Exhibit 99.1[4]. - The financial statements and exhibits are included in the filing[6]. Company Structure - The company became a fully remote organization effective July 1, 2024, and no longer maintains a principal executive office[3]. - The company has not indicated whether it is an emerging growth company[3]. Regulatory Information - The report is not deemed "filed" under the Securities Exchange Act of 1934[5]. - The report was signed by Alan Urban, Chief Financial Officer[11]. Company Identification - The company is listed on The Nasdaq Stock Market under the trading symbol GTBP[2]. - The company’s IRS Employer Identification Number is 94-1620407[1].

Phase 1 trial evaluating GTB-3650 TriKE® for relapsed or refractory (r/r) CD33 expressing hematologic malignancies continues to actively enroll with the next update anticipated in Q1 2026 GTB-5550 TriKE® IND submission for B7H3-expressing solid tumors expected in late December 2025 or January 2026 SAN FRANCISCO, CALIFORNIA, Nov. 14, 2025 (GLOBE NEWSWIRE) -- GT Biopharma, Inc. (the “Company”) (NASDAQ: GTBP), a clinical stage immuno-oncology company focused on developing innovative therapeutics based on the C ...

Market Overview - The market has seen significant declines among several companies, including Vantage Corp, ZIVO Bioscience, CCSC Technology, Thunder Power Holdings, and GT Biopharma, influenced by company-specific developments and broader market conditions [1]. Vantage Corp - Vantage Corp's stock price plummeted by 81.09% to $1.21, with a trading volume of 15,522,991, far exceeding its average [2]. - The company is scheduled to present at the 2025 Gateway Conference, which may provide an opportunity to showcase its services and potentially influence future stock performance [2]. CCSC Technology International Holdings - CCSC Technology experienced a 41.45% decrease in its stock price to $1.3701, with a trading volume spike to 11,391,387 [3]. - The company announced a memorandum of understanding with Konstruktor Group to develop a new supply chain management center in Serbia, aiming to enhance its logistics and manufacturing infrastructure in Europe [3]. Thunder Power Holdings - Thunder Power Holdings saw a 35.07% fall in its stock price to $0.19, with minimal trading activity [4]. - The company is focused on expanding its operations in Taiwan and is making strides in the clean energy market, which may impact its future stock performance [4]. GT Biopharma - GT Biopharma's stock decreased by 33.23% to $0.72, with a trading volume of 5,837,946 [5]. - The company is advancing its TriKE® platform for cancer treatment and has reported its financial results for the second quarter of 2025, which may influence investor sentiment and future stock movements [5]. Conclusion - These developments highlight the dynamic nature of the market, with company-specific news and strategic initiatives playing a crucial role in stock performance [6]. Investors are closely monitoring these companies for any updates that could impact their future trajectories [6].

Core Insights - The company is progressing well with Phase 1 enrollment, with both patients in Cohort 3 having initiated treatment without any dose-limiting toxicities or tolerability concerns to date [1][2] - The first patient in Cohort 3 has shown promising immune activation, consistent with previous cohorts, with further updates expected by year-end [1] - Upon successful completion of Cohort 3's safety assessment, the trial will escalate dosing into Cohort 4, planned for year-end 2025, with the potential to expand to 7 cohorts if necessary [1][2] Company Overview - GT Biopharma, Inc. is a clinical stage biopharmaceutical company focused on developing immuno-oncology therapeutics based on its proprietary TriKE NK cell engager platform [4] - The TriKE platform aims to enhance the cancer-killing abilities of natural killer cells in patients' immune systems [4] - The company holds an exclusive worldwide license agreement with the University of Minnesota for the development and commercialization of therapies utilizing TriKE technology [4] Trial Details - The Phase 1 trial protocol allows for the evaluation of GTB-3650 in approximately 14 patients across seven cohorts, with doses ranging from 1.25 µg/kg/day in Cohort 1 to 100 µg/kg/day in Cohort 7 [3] - Dosing will occur in two-week cycles, with treatment blocks lasting up to four months based on clinical benefit [3] - The trial will assess safety, pharmacokinetics, pharmacodynamics, in vivo expansion of endogenous NK cells, and clinical activity [3]

Core Insights - GT Biopharma, Inc. is a clinical stage immuno-oncology company focused on developing therapeutics based on its proprietary TriKE platform, which enhances the cancer-killing abilities of natural killer cells [1][3] - Michael Breen, the Executive Chairman and CEO, will participate in the Centurion One Capital 3rd Annual Bahamas Summit on October 28-29, 2025 [1] - The company will be available for one-on-one meetings at the conference, indicating an opportunity for potential investors to engage directly [2] Company Overview - GT Biopharma is dedicated to the development and commercialization of immuno-oncology therapeutic products utilizing the TriKE NK cell engager platform [3] - The company holds an exclusive worldwide license agreement with the University of Minnesota for the development and commercialization of therapies using TriKE technology [3] - For further information, the company directs interested parties to its website [3]

Summary of GT Biopharma Conference Call Company Overview - **Company Name**: GT Biopharma - **Ticker**: GTBP - **Industry**: Biotechnology, specifically focused on oncology and immunotherapy - **Current Stage**: Clinical-stage company conducting Phase 1 trials for blood cancer and acute myeloid leukemia [2][3] Core Technology and Pipeline - **Technology**: Trispecific killer cell engager camelid nanobodies designed to target cancer and HIV - **Pipeline**: Over six candidates in development, with plans to file an IND for solid tumors by the end of the calendar year [3] - **Key Focus**: Solid tumor oncology market, which is significantly larger than the blood cancer market [3] Clinical Trials and Findings - **GTB-3550**: First-generation TriKE® targeting CD33 for myeloid leukemia; well-tolerated with no safety issues reported [9][10] - **NK Cell Expansion**: The therapy demonstrated the ability to increase NK cell counts in patients, which is crucial for effective cancer treatment [10] - **GTB-3650**: Second-generation camelid TriKE® currently in trials, showing early signs of sustained immune activation and no dose-limiting toxicity [13][14] Advantages of Trispecific Engagers - **Unique Mechanism**: Combines IL-15 with NK cell engagement, enhancing the proliferation and activity of NK cells compared to other engagers that do not include IL-15 [19][20] - **Clinical Activity**: Preliminary data indicates potential clinical activity with reductions in leukemia blast cells observed in treated patients [11] Targeting B7H3 - **B7H3 TriKE®**: Developed to target a pan-tumor antigen, showing increased potency in preclinical models compared to first-generation engagers [12][16] - **Solid Tumor Trials**: Plans to conduct outpatient therapy with subcutaneous injections, aiming for a more manageable treatment regimen [18] Future Directions - **Basket Trials**: Seven cohorts planned to identify clinical activity across various diseases, which will inform the FDA approval pathway [19] - **Exploration of CD19 Targeting**: Investigating the potential of CD19 TriKE® for treating autoimmune diseases, with promising preclinical data [21][22] Conclusion - GT Biopharma is positioned to leverage its innovative trispecific engager technology to address significant unmet needs in oncology, with a focus on both blood cancers and solid tumors, while also exploring applications in autoimmune diseases. The company aims to advance its clinical trials and seek FDA approval in the coming years [2][19]

Company Overview - GT Biopharma, Inc. is a clinical stage immuno-oncology company focused on developing therapeutics based on its proprietary TriKE platform, which enhances the cancer-killing abilities of natural killer (NK) cells [2][4] - The company has an exclusive worldwide license agreement with the University of Minnesota to further develop and commercialize therapies using TriKE technology [2] Upcoming Events - The company will participate in the H.C. Wainwright 27th Annual Global Investment Conference from September 8-10, 2025, in New York City [1] - An on-demand webcast of the company's presentation will be available starting at 7:00 a.m. ET on September 5, 2025 [2] Clinical Trials - The Phase 1 trial for GTBP-3650, aimed at treating relapsed or refractory CD33 expressing hematologic malignancies, is continuing to enroll as expected, with initial results from multiple dose cohorts anticipated later in 2025 [1] - The company is on track for the IND submission of GTB-5550 TriKE for the treatment of B7H3 positive solid tumors in Q4 2025 [1]

Core Viewpoint - GT Biopharma, Inc. reported positive progress in its Phase 1 clinical trial for GTB-3650, with a successful safety review and plans for further data release later in 2025 [2][8]. Financial Summary - As of June 30, 2025, the company had cash and cash equivalents of approximately $5.3 million, expected to fund operations into Q1 2026 [3][8]. - Research and Development (R&D) expenses for Q2 2025 were approximately $400,000, a decrease from $1.8 million in Q2 2024, primarily due to reduced production and scientific research costs [4]. - Selling, General and Administrative (SG&A) expenses for Q2 2025 were approximately $1.1 million, down from $2.0 million in the same quarter of 2024, attributed to lower legal fees and cost reduction measures [5]. - The company reported a net loss of approximately $1.4 million for Q2 2025, compared to a net loss of $3.7 million in Q2 2024, reflecting significant decreases in R&D and SG&A expenses [6]. Clinical Development - The Phase 1 trial for GTB-3650 is evaluating the treatment in 12 patients with relapsed or refractory CD33 expressing hematologic malignancies, with dosing structured in two-week blocks [2]. - The trial has successfully completed Cohort 1 and Cohort 2, advancing into Cohort 3, with initial data expected later in 2025 [8]. - The company anticipates submitting an IND application for GTB-5550, targeting B7H3 positive solid tumors, in Q4 2025 [8]. Company Overview - GT Biopharma is focused on developing immuno-oncology therapeutics based on its proprietary TriKE NK cell engager platform, which enhances the cancer-killing abilities of natural killer cells [9]. - The company holds an exclusive worldwide license agreement with the University of Minnesota for the development and commercialization of therapies using TriKE technology [9].